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Astellas submits MAA for wider use of prostate cancer drug Xtandi in EuropeAstellas Pharma and Medivation have submitted a variation to amend the European marketing authorisation application (MAA) for Xtandi (enzalutamide) capsules to treat adult men with metastatic castrati2014/4/9
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Critical Outcome seeks FDA orphan drug status for ovarian cancer drug COTI-2Canada-based bioinformatics and accelerated drug discovery firm Critical Outcome Technologies (COTI) has submitted an orphan drug application to the US Food and Drug Administration (FDA) for its lead2014/4/8
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FDA Approves New Hand-Held Auto-Injector to Reverse Opioid Overdose‏Yesterday (3 April)FDAapproved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochlor2014/4/8
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PHEXTOUR Pharma Excipients Application Technology (Great China) Tour Seminar--TaipeiFor the sake of promoting the communication between Taiwan Pharmaceutical companied and excipients company from mainland and oversea; and encourage pharmaceutical companiesto make good use of advanc2014/4/4
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Erytech gets FDA orphan drug status for ERY-ASP in acute myeloid leukaemiaFrench biopharmaceutical firm Erytech Pharma has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its lead product GRASPA/ERY-ASP for treatment of acute myeloi2014/4/4
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European Commission approves Bayer's Adempas to treat two forms of pulmonary hypertensionThe European Commission has approved Bayer's Adempas (riociguat) for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) in the European Un2014/4/4
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Stallergenes obtains US FDA approval for pollen allergy drug OralairFrance-based Stallergenes has secured US Food and Drug Administration (FDA) approval for its immunotherapy tablet Oralair for treatment of grass pollen-induced allergic rhinitis with or without conjun2014/4/3
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Dainippon's schizophrenia drug Latuda obtains European approvalThe European Commission (EC) has granted marketing authorisation for Japanese pharmaceutical firm Dainippon Sumitomo Pharma's (DSP's) once-daily oral Latuda (lurasidone) for treatment of schizophrenia2014/4/3
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Roche's subcutaneous formulation of lymphoma drug MabThera gets approval in EuropeThe European Commission (EC) has approved Roche's new subcutaneous (SC) formulation of MabThera (rituximab) for treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. This2014/4/2
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GSK Announces New Strategic Investments in Africa to Increase Access to Medicines, Build Capacity and Deliver Sustainable GrowthYesterday (31 March 2014), GSK announced a series of new investments in sub-Saharan Africa designed to address pressing health needs and contribute to long-term business growth. Speaking at the 5th EU2014/4/2